PARI Pharma's eFlow
electronic nebulizer was included in Gilead's (Nasdaq: GILD) recent New
Drug Application (NDA) submittal to the U.S. Food and Drug Administration
(FDA) for marketing approval of aztreonam lysine for inhalation (75 mg
three times daily). Aztreonam lysine for inhalation, delivered by eFlow, is
an investigational therapy in development for people with cystic fibrosis
(CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection.
The NDA is supported by data from two Phase III clinical studies
(AIR-CF1 and AIR-CF2) and interim data from an ongoing open-label extension
study (AIR- CF3) of patients who participated in AIR-CF1 or AIR-CF2 where
eFlow was used exclusively in these trials. The model of the eFlow device
used in the trials was optimized from the eFlow platform to deliver the
aerosol formulation of aztreonam lysine for inhalation. Aztreonam lysine
for inhalation was administered over a two to three minute period in these
studies. This represents a significant reduction in aerosol treatment
times, as currently available inhalation therapies can average 20 to 25
minutes.
PARI Pharma GmbH, the developer of the eFlow, also contributed to the
development and optimization of the drug formulation (aztreonam lysine for
inhalation) for delivery with the specific eFlow.
eFlow, an electronic, portable nebulizer, enables extremely efficient
aerosolization of liquid medications via a vibrating, perforated membrane
that includes thousands of small holes that produce the aerosol mist.
Compared to other nebulizer systems, eFlow can produce aerosols with a very
high density of active drug, a precisely defined droplet size, and a high
proportion of respirable droplets delivered in the shortest possible period
of time. Combined with its silent mode of operation, small size (it fits in
the palm of your hand), light weight, and battery use, eFlow helps reduce
the burden of taking daily, inhaled treatments.
Aztreonam lysine for inhalation is an investigational therapy and has
not yet been determined safe or efficacious in humans.
About Cystic Fibrosis
Today, more than 30,000 people in the United States have CF. CF is a
chronic, debilitating genetic disease. A major characteristic of CF is
production of abnormally thick, sticky mucus in the lungs, trapping
bacteria and predisposing patients to lung infections, which continually
damage their lungs.
Pulmonary infection with Gram-negative bacteria, particularly pulmonary
P. aeruginosa, represents the single greatest cause of morbidity and
mortality among CF patients. Currently there is no known cure for CF, and
the goal of CF therapy is to control symptoms and prevent further lung
damage.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical need.
Headquartered in Foster City, California, Gilead has operations in North
America, Europe and Australia.
About PARI Pharma
PARI Pharma focuses on the development of aerosol delivery devices and
therapies. Based on PARI's 100-year history working with aerosols, PARI
Pharma develops treatments for pulmonary and nasal administration optimized
to advanced delivery platforms, such as eFlow.
PARI Pharma provides comprehensive inhalation drug development,
including nebulizer formulation development and optimization, CMC,
analytics, aerosol characterization, clinical protocol development, and
regulatory guidance. PARI Pharma has several clinical development programs
ongoing, either partnered or on its own. PARI Pharma, a PARI Medical
Holding company, is located in Munich, Germany with a major presence in the
United States. Online at paripharma
PARI Pharma
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